Portable Infusion Pump and Media Player

ABSTRACT

Some embodiments of a portable infusion pump system can be configured to deliver medicine (e.g., insulin or the like) to a user and to deliver media content to a user. The media content can include, for example, MP3 music and other audio/video data stored in a memory device in the portable system. Thus, in particular embodiments, the portable infusion pump system can serve a dual purpose of providing medication and entertainment for the user from a compact and unobtrusive device.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This is a continuation of U.S. application Ser. No. 13/613,375 filed onSep. 13, 2012 which is a continuation of U.S. application Ser. No.12/968,741 filed on Dec. 15, 2010 (now U.S. Pat. No. 8,282,626), whichis a division application of U.S. application Ser. No. 11/954,755 filedon Dec. 12, 2007 (now U.S. Pat. No. 7,875,022), the contents of theseprevious applications are incorporated herein by reference.

TECHNICAL FIELD

This document relates to portable infusion pump systems to deliverfluids, such as insulin infusion pumps or the like.

BACKGROUND

Pump devices are commonly used to deliver one or more fluids to atargeted individual. For example, a medical infusion pump device may beused to deliver a medicine to a patient as part of a medical treatment.The medicine that is delivered by the infusion pump device can depend onthe condition of the patient and the desired treatment plan. Forexample, infusion pump devices have been used to deliver insulin to thevasculature of diabetes patients so as to regulate blood-glucose levels.

SUMMARY

Some embodiments of a portable infusion pump system can be configured todeliver medicine (e.g., insulin or the like) to a user while alsodelivering media content to the user. The media content can include, forexample, MP3 music data or other audio/video data stored in a memorydevice in the portable system. Thus, in particular embodiments, theportable infusion pump system can serve a dual purpose of providingmedication and entertainment for the user from a compact and unobtrusivedevice. Moreover, the infusion pump system may be used to deliver alarmsthat alert the user when the pump system requires user action oracknowledgement. In such circumstances, the pump system can beconfigured to interrupt the music content or other media content inorder to deliver the alarm via the user's listening device (e.g.,earbuds, other headphone device, or the like), thereby enhancing safetywhere the user might otherwise miss the alarm.

In particular embodiments, a medical infusion pump system may include aportable housing defining a space to receive a medicine. The system mayalso include a pump drive system to dispense medicine to a user from thehousing when the medicine is received in the space. Further, the systemmay include a controller that electrically communicates with the pumpdrive system to transmit activation signals to the pump drive system.The system may also include an external audio device that communicateswith at least a portion of the controller. The controller may accessdigital music content stored in a memory device to output selected musicthrough the external audio device to the user. Also, the controller mayinterrupt the selected music output through the external audio device tothe user in response to a medicine dispensation alarm condition.

Some embodiments described herein include a method of operating amedical infusion pump system. The method may include activating a pumpdrive system of a portable infusion pump system to dispense medicine toa user according to set parameters. Also, the method may includeaccessing digital music content stored in a memory device of theportable infusion pump system to output selected music through anexternal audio device to the user. The method may further include, inresponse to a detected alarm condition of the portable infusion pumpsystem, interrupting the selected music output through the externalaudio device to the user so as to deliver an audible alert through theexternal audio device.

In certain embodiments, a medical infusion pump system may include aportable housing defining a space to receive a medicine. The system mayalso include a pump drive system to dispense medicine to a user from thehousing when the medicine is received in the space. The system mayfurther include a controller that electrically communicates with thepump drive system to transmit activation signals to the pump drivesystem. The system may further include a media content playback systemthat communicates with at least a portion of the controller to outputselected media content to the user. The controller may accessinstructional media content stored in a memory device to output tutorialinformation through the media content playback system to the user. Thetutorial information may communicate actions to be performed by the userof the medical infusion pump system.

In some embodiments, a medical infusion pump system may include aportable housing defining a space to receive a medicine, and a pumpdrive system to dispense medicine to a user from the housing when themedicine is received in the space. The system may also include acontroller that electrically communicates activation signals to the pumpdrive system to control the dispensation of the medicine. The system mayfurther include a media content playback system having an external audiodevice connectable to the controller so as to output selected mediacontent to the user. The controller may access digital media contentstored in a memory device to output selected media content through theexternal audio device to the user. The system may also include a userinterface electrically coupled to the controller. The user interface mayinclude a display device that contemporaneously displays medicinaldelivery information and media content playback information.

Some embodiments described herein include a method of using a medicalinfusion pump system. The method may include actuating one or morebuttons of a user interface of a portable infusion pump system so as toadjust a pump parameter. The portable infusion pump system may have apump drive system to dispense medicine to a user according to theparameter. The method may also include actuating one or more buttons ofthe user interface to select media content for playback through anexternal audio device to the user. The selected media content may bestored with a plurality of digital media content files in a memorydevice of the portable infusion pump system. The method may furtherinclude contemporaneously receiving the medicine dispensed from theportable infusion pump system and receiving the playback of the selectedmedia content output by the portable infusion pump system.

Some or all of the embodiments described herein may provide one or moreof the following advantages: First, some embodiments of an infusion pumpsystem can be capable of infusing medication (e.g., insulin or the like)to a user while also delivering audio or video media content to theuser, thereby proving provide both medication infusion and entertainmentoutput for the user. As such, there may be no need for the user to carryand operate a separate media playback device, thereby simplifying theprocess for selecting and receiving media playback and reducing thenumber of devices that must be carried by the user. Second, the infusionpump system can be configured to be compact and unobtrusive device,which provides a system that is readily portable and wearable. Third,the user can contemporaneously monitor infusion pump operation andcontrol the media content playback from the same user interface on theportable system. Fourth, in some embodiments, the pump system can beconfigured to interrupt the music content or other media content inorder to deliver an alarm via the user's external audio device (e.g.,earbud device, other headphone device, or the like), thereby enhancingthe user safety. Fifth, the media content played by the pump system mayinclude an audio tutorial or other instructional content on how tooperate particular features of the pump system, which can facilitate newuser training in a manner that is helpful for children or other users inneed of further training outside of a clinic environment.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of an infusion pump system in accordancewith some embodiments.

FIG. 2 is another perspective view of the infusion pump system of FIG.1.

FIG. 3 is another perspective view of the infusion pump system of FIG.1.

FIG. 4 is a perspective view of an infusion pump system in accordancewith some embodiments.

FIG. 5 is a perspective view of an infusion pump system in accordancewith particular embodiments.

FIG. 6 is a perspective view of an infusion pump system that receives aremovable memory device, in accordance with some embodiments.

FIG. 7 is a perspective view of an infusion pump system that receives acomputer interface cable, in accordance with some embodiments.

FIG. 8 is a perspective view of an infusion pump system that receivesanother computer interface cable, in accordance with certainembodiments.

FIG. 9 is a perspective view of the infusion pump system worn onclothing of a user, in accordance with some embodiments.

FIG. 10 is a perspective view of an infusion pump system worn on skin ofa user, in accordance with particular embodiments.

FIGS. 11-12 are perspective views of a pump device being detached from acontroller device, in accordance with some embodiments.

FIGS. 13-14 are perspective views of the pump device of FIGS. 11-12being discarded and the controller device of FIGS. 11-12 being reusedwith a new pump device.

FIGS. 15-16 are perspective views of the new pump device of FIG. 13being attached to the controller device of FIG. 13.

FIG. 17 is an exploded perspective view of a controller device for aninfusion pump system, in accordance with some embodiments.

FIG. 18 is a perspective view of a pump device (with a housing portionremoved) for an infusion pump system, in accordance with someembodiments.

FIG. 19 is a diagram of an infusion pump system configured to delivermedicine to a user and to deliver media content to a user, in accordancewith some embodiments.

FIGS. 20 A-B are perspective views of the infusion pump systemdisplaying a collection of media content for playback to a user, inaccordance with some embodiments.

FIGS. 21 A-B are perspective views of the infusion pump system promptinga user to receive instructional media content, in accordance with someembodiments.

FIG. 22 is a perspective view of another pump system configured todeliver medicine to a user and to deliver media content to a user, inaccordance with certain embodiments.

FIG. 23 is a perspective view of an alternative pump system configuredto deliver medicine to a user and to deliver media content to a user, inaccordance with some embodiments.

FIG. 24 is a perspective view of yet another pump system configured todeliver medicine to a user and to deliver media content to a user, inaccordance with particular embodiments.

FIG. 25 is a chart describing a process for delivering an alert to auser of an infusion pump system, in accordance with some embodiments.

FIG. 26 is a chart describing a process for delivering instructionalmedia content to a user of an infusion pump system, in accordance withsome embodiments.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Some embodiments of an infusion pump system can serve a dual purpose ofproviding medication and entertainment for the user from a compact andunobtrusive device. For example, an infusion pump system can be portableand wearable such that the system is capable of infusing medication(e.g., insulin or the like) to a user while also delivering digitalaudio/video media content to the user. In such circumstances, the pumpsystem can interrupt the music content or other media content in orderto deliver the alarm via the user's earbuds or other headphone device,which enhances user safety where the user might otherwise miss thealarm. Also, the media content stored in, and output by, the pump system10 may include an audio tutorial or other instructional content on howto operate particular features of the system, thereby facilitating newuser training. As described in more detail below, particular embodimentsof the infusion pump system may include a disposable pump device, andother embodiments may include a reusable pump device.

Referring now to FIGS. 1-3, some embodiments of an infusion pump system10 can include a pump device 100 and a controller device 200 that cancommunicate with the pump device 100. The pump device 100 can include ahousing structure 110 that defines a cavity 116 in which a fluidcartridge 120 can be received. The pump device 100 also can include acap device 130 to retain the fluid cartridge 120 in the cavity 116 ofthe housing structure 110. The pump device 100 can include a drivesystem (described in more detail below) that advances a plunger 125 inthe fluid cartridge 120 so as to dispense fluid therefrom. Thecontroller device 200 can communicate with the pump device 100 tocontrol the operation of the drive system. When the controller device200, the pump device 100 (including the cap device 130), and the fluidcartridge 120 are assembled together, the user can (in some embodiments)conveniently wear the infusion pump system 10 on the user's skin underclothing or in the user's pocket while receiving the fluid dispensedfrom the pump device 100.

The controller device 200 may be configured as a reusable component thatprovides electronics and a user interface to control the operation ofthe pump device 100. In such circumstances, the pump device 100 can be adisposable component that is discarded after a single use. For example,as described in more detail below in connection with FIGS. 11-16, thepump device 100 can be a “one time use” component that is thrown awayafter the fluid cartridge 120 therein is exhausted. Thereafter, the usercan removably attach a new pump device 100′ (having a new medicinecartridge 120′ as shown in FIG. 13) to the reusable controller device200 for the dispensation of fluid from a new fluid cartridge 120′.Accordingly, the user is permitted to reuse the controller device 200(which may include valuable electronics or data) while disposing of therelatively low-cost pump device 100 after each use. Such a pump system10 can provide enhanced user safety as a new pump device 100 (and drivesystem therein) is employed with each new fluid cartridge 120.

Still referring to FIGS. 1-3, the infusion pump system 10 may alsoinclude an media content playback system 230 that can playback digitalmedia content (e.g., music, voice instructions, audiobooks, audio thatcorresponds to a video being displayed, and other data) to the userwhile the pump system 10 is delivering the medicine to the user. Theplayback system 230 may comprise, for example, an external audio device231 that plugs into a connection port 234 (refer to FIG. 17) so as tomate with an audio jack 232 housed by the controller device 200.Furthermore, the playback system 230 can output to the user mediacontent that is electronically stored in one or more memory devices 246(refer to FIG. 17) arranged in the controller device 200. Accordingly,the user can operate the infusion pump system 10 so as to receivecontrolled delivery of a medicine 126 while also viewing and/orlistening to the playback of selected music, video, or other mediacontent (e.g., playback of MP3, WMA, WMV, or DIVX files). In suchembodiments, the pump system 10 may provide a compact, multi-purposedevice that eliminates the need for the user to carry multiple devices(e.g., a medical pump device and a separate media player device).Moreover, the infusion pump system 10 can enhance user safety byinterrupting the music content or other media content in order todeliver an alarm to the user that might otherwise go unnoticed if theuser was listening to a separate media player device.

Briefly, in use, the pump device 100 can be configured to be removablyattached to the controller device 200 in a manner that provides a securefitting, an overall compact size, and a reliable electrical connectionthat is resistant to water migration. For example, as described in moredetail below in connection with FIGS. 11-16, the controller device 200can include a housing 210 having a number of features that mate withcomplementary features of the pump housing 110. In such circumstances,the controller device 200 can be removably attached to the pump device100 in a generally side-by-side configuration while not fullysurrounding the pump housing 110. Accordingly, in this embodiments, thepump device 100 and the controller device 200 can be separate componentsthat fit together, but the overall size of the combined assembly can bereduced because there is no requirement for one component (e.g., thecontroller device) to completely surround or envelop the secondcomponent (e.g., the pump device). The compact size permits the infusionpump system 10 to be discrete and portable (as described below inconnection with FIGS. 9-10). Moreover, at least one of the pump device100 or the controller device 200 can include a release member thatfacilitates an easy-to-use detachment and replacement process.

Referring again to FIGS. 1-3, the pump system 10 can be a medicalinfusion pump system that is configured to controllably dispense amedicine from the cartridge 120. As such, the fluid cartridge 120 cancontain a medicine 126 (FIG. 1) to be infused into the tissue orvasculature of a targeted individual, such as a human or animal patient.For example, the pump device 100 can be adapted to receive a medicinecartridge 120 in the form of a carpule that is preloaded with insulin oranother medicine for use in the treatment of Diabetes (e.g., Byetta®,Symlin®, or others). Such a cartridge 120 may be supplied, for example,by Eli Lilly and Co. of Indianapolis, Ind. Other examples of medicinescontained in the fluid cartridge 120 include: pain relief drugs, hormonetherapy, blood pressure treatments, anti-emetics, osteoporosistreatments, or other injectable medicines. The fluid cartridge 120 mayhave other configurations. For example, the fluid cartridge may comprisea reservoir that is integral with the pump housing structure 110 (e.g.,the fluid cartridge can be defined by one or more walls of the pumphousing structure 110 that surround a plunger to define a reservoir inwhich the medicine is injected or otherwise received).

In some embodiments, the pump device 100 can include one or morestructures that interfere with the removal of the medicine cartridge 120after the medicine cartridge 120 is inserted into the cavity 116. Forexample, as shown in FIG. 1, the pump housing structure 110 can includeone or more retainer wings 119 that at least partially extend into thecavity 116 to engage a portion of the medicine cartridge 120 when themedicine cartridge 120 is installed therein. Such a configuration mayfacilitate the “one-time-use” feature of the pump device 100. In someembodiments, the retainer wings 119 interfere with attempts to removethe medicine cartridge 120 from the pump device 100, thus ensuring thatthe pump device 100 will be discarded along with the medicine cartridge120 after the medicine cartridge 120 is emptied, expired, or otherwiseexhausted. Accordingly, the pump device 100 can operate in atamper-resistant and safe manner because the pump device 100 can bedesigned with predetermined life expectancy (e.g., the “one-time-use”feature in which the pump device is discarded after the medicinecartridge 120 is emptied, expired, or otherwise exhausted).

Still referring to FIGS. 1-3, the controller device 200 can be removablyattached to the pump device 100 so that the two components aremechanically mounted to one another in a fixed relationship. Such amechanical mounting can form an electrical connection between theremovable controller device 200 and the pump device 100. For example,the controller device 200 can be in electrical communication with aportion of a drive system (not shown in FIGS. 1-3, refer to FIG. 18) ofthe pump device 100. As described in more detail below, the pump device100 can include a drive system that causes controlled dispensation ofthe medicine or other fluid from the cartridge 120. In some embodiments,the drive system incrementally advances a piston rod (not shown in FIGS.1-3) longitudinally into the cartridge 120 so that the fluid is forcedout of an output end 122. A septum 121 (FIG. 1) at the output end 122 ofthe fluid cartridge 120 can be pierced to permit fluid outflow when thecap device 130 is connected to the pump housing structure 110 (describedin more detail below). Thus, when the pump device 100 and the controllerdevice 200 are attached and thereby electrically connected, thecontroller device 200 can communicate electronic control signals via ahardwire-connection (e.g., electrical contacts or the like) to the drivesystem or other components of the pump device 100. In response to theelectrical control signals from the controller device 200, the drivesystem of the pump device 100 causes medicine to incrementally dispensefrom the medicine cartridge 120.

As shown in FIG. 1, the pump device 100 can include an electricalconnector 118 (e.g., having conductive pads, pins, and the like) thatare exposed to the controller device 200 and that mate with acomplementary electrical connector (refer to connector 218 in FIG. 8) onthe adjacent face of the controller device 200. The electricalconnectors 118 and 218 provide the electrical communication between thecontrol circuitry (refer, for example, to FIG. 17) housed in thecontroller device 200 and at least a portion of the drive system orother components of the pump device 100. For example, in someembodiments, the electrical connectors 118 and 218 can permit thetransmission of electrical control signals to the pump device 100 andthe reception of feedback signals (e.g., sensor signals) from particularcomponents within the pump device 100. Furthermore, the infusion pumpsystem 10 can include a gasket 140 that provides a seal around theelectrical connector interface to thereby resist migration of externalcontaminants when the pump device 100 is attached to the controllerdevice 200. Thus, in some embodiments, the infusion pump system 10 canbe assembled into a water resistant configuration that protects theelectrical interconnection from water migration (e.g., if the userencounters water while carrying the pump system 10).

Still referring to FIGS. 1-3, the controller device 200 can include auser interface 220 that permits a user to monitor the operation of thepump device 100. In some embodiments, the user interface 220 includes adisplay device 222 and one or more user-selectable buttons (e.g., fourbuttons 224 a, 224 b, 224 c, and 224 d in this embodiment). The displaydevice 222 can include an active area in which numerals, text, symbols,images, or a combination thereof can be displayed (refer, for example,to FIG. 2). For example, the display device 222 can be used tocommunicate media content information 226, which may related to theselected media content that is being delivered to the user through theplayback system 230. Also, the display device 222 can be used tocommunicate a number of settings or menu options for the infusion pumpsystem 10. For example, the display device 222 can be used tocommunicate medicinal delivery information 227, such as the basaldelivery rate (as shown in FIG. 1), a bolus dosage, a historical recordof medicine delivered, the amount of medicine remaining in the cartridge120, or the like. In another example, the display device 222 can be usedto communicate time and date information 228, which can be used by theuser to determine dosage schedules, bolus delivery times, meal times, orthe like.

In this embodiment, the user may press one or more of the buttons 224 a,224 b, 224 c, and 224 d to shuffle through a number of menus or programscreens that show particular settings and data (e.g., review data thatshows the medicine dispensing rate, the total amount of medicinedispensed in a given time period, the amount of medicine scheduled to bedispensed at a particular time or date, the approximate amount ofmedicine remaining in the cartridge 120, or the like). In someembodiments, the user can adjust the settings or otherwise program thecontroller device 200 by pressing one or more buttons 224 a, 224 b, 224c, and 224 d of the user interface 220. For example, in embodiments ofthe infusion pump system 10 configured to dispense insulin, the user maypress one or more of the buttons 224 a, 224 b, 224 c, and 224 d tochange the dispensation rate of insulin or to request that a bolus ofinsulin be dispensed immediately or at a scheduled, later time.Accordingly, when the controller device 200 is connected to the pumpdevice 100, the user can be provided with the opportunity to readilymonitor infusion pump operation by simply viewing the user interface 220of the controller device 200 connected to the pump device 100. Suchmonitoring capabilities may provide comfort to a user who may haveurgent questions about the current operation of the pump device 100.Also, in these embodiments, there may be no need for the user to carryand operate a separate module to monitor the operation of the infusionpump device 100, thereby simplifying the monitoring process and reducingthe number of devices that must be carried by the user. If a need arisesin which the user desires to monitor the operation of the pump device100 or to adjust settings of the pump system 10 (e.g., to request abolus amount of medicine), the user can readily operate the userinterface 220 of the controller device 200, which is removably attachedto the pump device 100, without the requirement of locating andoperating a separate monitoring module.

In another example, the user can press one or more of the buttons 224 a,224 b, 224 c, and 224 d of the user interface 220 to play, pause,rewind, or fast-forward the selected media content 226 or to otherwisecontrol the output of media content through the playback system 230.Thus, when the controller device 200 is connected to the pump device100, the user can contemporaneously monitor infusion pump operation andcontrol the media content playback from the same user interface 220.Again, in these embodiments, there may be no need for the user to carryand operate a separate media playback device, thereby simplifying theprocess for selecting and receiving media playback and reducing thenumber of devices that must be carried by the user. Furthermore, in someembodiments, the pump system 10 can be configured to interrupt the musiccontent or other media content in order to deliver an alarm via theuser's external audio device 231 (e.g., earbud device, other headphonedevice, or the like), thereby enhancing the user safety. Finally, themedia content played by the pump system 10 may include an audio tutorialor other instructional content on how to operate particular features ofthe system, which facilitates new user training (especially for childrenor other young users).

Referring to now FIGS. 2-3, the infusion pump system 10 may beconfigured to be portable so that the user can readily carry or wear thepump system during operation. For example, a user can conveniently wearthe infusion pump system 10 on the user's skin (e.g., skin adhesive)underneath the user's clothing or carry the pump device 100 in theuser's pocket (or other portable location) while both receiving themedicine dispensed from the pump device 100 and receiving the playbackof the selected media content. As described below in connection withFIG. 18, the drive system of the pump device 100 may be arranged in acompact manner so that the pump device 100 has a reduced length. Forexample, in the circumstances in which the medicine cartridge 120 has alength of about 6 cm to about 7 cm (about 6.4 cm in one embodiment), theoverall length of the pump housing structure 110 (which containsmedicine cartridge and the drive system) can be about 7 cm to about 10cm and about 7 cm to about 9 cm (about 8.3 cm or less in oneembodiment). In addition, the pump housing structure 110 may have anoverall height of about 2 cm to about 4 cm (about 3.1 cm or less in oneembodiment) and an overall thickness of about 8 mm to about 20 mm (about17.5 mm or less in one embodiment). In such circumstances, thecontroller device 200 can be figured to mate with the pump housing 110so that, when removably attached to one another, the components define aportable infusion pump system that stores a relatively large quantity ofmedicine compared to the overall size of the unit. For example, in thisembodiment, the infusion pump system 10 (including the removablecontroller device 200 attached to the pump device 100 having the cap130) may have an overall length of about 7 cm to about 10 cm (about 9.3cm or less in one embodiment), an overall height of about 2 cm to about5 cm (about 4.2 cm or less in one embodiment), and an overall thicknessof about 8 mm to about 20 mm (about 17.5 mm or less in one embodiment).

The pump system 10 is shown in FIGS. 2-3 as being held in a user's hand5 so as to illustrate an exemplary size of the system 10 in accordancewith some embodiments. This embodiment of the infusion pump system 10 iscompact so that the user can wear the portable infusion pump system 10(e.g., in the user's pocket, connected to a belt clip, adhered to theuser's skin, or the like) and receive the playback of the selected mediacontent without the need for carrying and operating a separate module.In such embodiments, the pump device 100 can deliver the medicine 126through an infusion set 146, and the controller device can deliver theselected media content through the external audio device 231.

The infusion set 146 includes tubing system that connects the infusionpump system 10 to the tissue or vasculature of the user (e.g., todeliver medicine into the tissue or vasculature under the user's skin).The infusion set 146 may include a flexible tube 147 that extends fromthe pump device 100 to a subcutaneous cannula 149 retained by a skinadhesive patch 148 that secures the subcutaneous cannula 149 to theinfusion site. The skin adhesive patch 148 can retain the infusioncannula 149 in fluid communication with the tissue or vasculature of thepatient so that the medicine dispensed through the tube 147 passesthrough the cannula 149 and into the user's body. The cap device 130 mayprovide fluid communication between the output end 122 (FIG. 1) of themedicine cartridge 120 and the tube 147 of the infusion set 146. Forexample, the tube 147 may be directly connected to the output port 139(FIG. 1) of the cap device 130. In another example, the infusion set 146may include a connector (e.g., a Leur connector or the like) attached tothe tube 147, and the connector can then mate with the cap device 130 toprovide the fluid communication to the tube 147. In these examples, theuser can carry the portable infusion pump system 10 (e.g., in the user'spocket, connected to a belt clip, adhered to the user's skin, or thelike) while the tube 147 extends to the location in which the skin ispenetrated for infusion. If the user desires to monitor the operation ofthe pump device 100 or to adjust the settings of the infusion pumpsystem 10, the user can readily access the user interface 220 of thecontroller device 200 without the need for carrying and operating aseparate module

Still referring to FIGS. 2-3, the external audio device 231 can includeone or more earbuds 235 that fit with the user's ear so as to direct theaudio content into the ear for personal listening. The external audiodevice 231 can be used to deliver selected audio content 236 (refer toFIG. 2) for the user's listening enjoyment, but may also be used tointerrupt the selected audio content to deliver an audible alert 237(refer to FIG. 3) that notifies the user of a warning or conditionrelated to the medicine delivery of the pump system 10. For example, theuser can operate the user interface 220 of the controller device 200 sothat the selected music content 236 is output through the earbuds 235 tothe user's ear. The media content information 226 can be shown in thedisplay device 222 of the pump system 10 to indicate that the selectedmedia content is now playing (refer, for example, to the “now playing”triangle symbol adjacent to the information 226 indicating the songtitle and artist as shown in FIG. 2). This may occur while the pumpsystem is also operating to deliver controlled dosages of the medicine126 to the user via the infusion set 146.

In the event that an alarm condition (e.g., low power, low medicinevolume, occlusion detection, drive system or electrical communicationerror, or the like) is detected by the pump system 10, one or both ofthe external audio device 231 and the display device 222 can be used tocommunicate an alert 237 to the user. For example, as shown in FIG. 3,if the pump system 10 detects an occlusion in the medicine flow path(which can cause inaccurate dosage delivery), an audible alert 237 canbe used to interrupt the playback of the music content 236 (FIG. 2) andnotify the user of the detected occlusion. The audible alert 237 may bein the form of an alert beep, a voice notification, or a combinationthereof. In particular embodiments, the audible alert 237 can include avoice notification that states: “Alert. An occlusion has been detected.Please check the infusion set for blockages.” In addition, the displaydevice 222 of the controller 200 can be used to indicate that the musiccontent 236 (FIG. 2) has been interrupted due to the detection of analarm condition. For example, the display device 222 can indicate thatthe media content has automatically switched to a paused or stoppedcondition (refer, for example, to FIG. 3 which shows the “paused” symbolin the area formerly occupied by the media content information 226).Also, the display device 222 may provide a visual alert 227 thatindicates the detected alarm condition.

In some circumstances, the playback of the media content may resumeafter the alert 237 (FIG. 3) has been communicated. For example, somealarm conditions may not require immediate intervention on the part ofthe user (e.g., a warning that the medicine cartridge 120 is 80%exhausted). Accordingly, the alert 237 may temporarily interrupt themusic content 236 before the controller device 200 automatically resumesthe playback of the music content. In other circumstances, the playbackof the media content may remain in the paused state until the useracknowledges receipt of the alarm communication. For example, as shownin FIG. 3, the user can acknowledge the alarm communication by pressingthe button 224 b adjacent to the “clear” command. Other alarm conditionsmay require further intervention by the user. In those situations, theaudible alert 237 may include voice instructions that indicate theactions to be performed by the user.

Referring now to FIGS. 4-5, the media content playback system 230 candeliver the selected media content to the user via a hardwiredconnection to the external audio device 231 (FIG. 4) or a wireless linkto at least one body-worn earpiece 235′ (FIG. 5). As previouslydescribed, the infusion pump system 10 can be worn by the user (e.g., inthe user's pocket, connected to a belt clip, adhered to the user's skin,or the like) while delivering playback of the selected media content tothe user's ear 6. Thus, as shown in FIGS. 4-5, the pump system 10 candeliver the medicine 126 through the infusion set 146 adhered to theuser's skin surface while contemporaneously outputting music content orother audio content to the user's ear 6.

In the embodiment depicted in FIG. 4, the external audio device 231comprises a cable connection between the earbuds 235 and the audio jack232 (FIG. 17) housed in the controller device 200. Accordingly, the usercan arrange the pump system 10 so that the tubing 147 of the infusionset 146 extends from the pump device 100 to a targeted location on theuser's skin and the cable of the external audio device 231 extends fromthe controller device 200 to the user's ear 6.

In alternative embodiments, the playback system 230 can include awireless link to the earpiece so as to eliminate the audio cableextending from the pump system 10. For example, in the embodimentdepicted in FIG. 5, the playback system 230 can include a wirelesstransmitter 231′ that communicates media content data to a wirelessearpiece device 235′. The media content transmitter 231′ can outputshort-range signals (e.g., Bluetooth signals, RF signals, or the like)indicative of the audio content that is to be output from the speaker inthe earpiece 235′. In this embodiment, the transmitter 231′ is housed inthe controller device 200 and is electrically connected to the controlcircuitry 240 therein (FIG. 17). The earpiece 235′ can include anantenna and a wireless receiver arranged, for example, in a body-wornhousing that is shaped to rest on the user's ear. As such, the wirelesssignals from the transmitter 231′ are received by the earpiece 235's tothereby output the audio content into the user's ear 6. As previouslydescribed, the user can arrange the pump system 10 so that the tubing147 of the infusion set 146 extends from the pump device 100 to atargeted location on the user's skin. However, in this embodiment, theuser need not arrange the pump system 10 in a manner that accounts foran audio cable extending from pump system 10 because the earpiece 235′can receive the audio content information via the wireless link.

Referring now to FIG. 6, some embodiments of the playback system 230 canoperate with a removable memory card 250 that stores one or more mediacontent files thereon. For example, the user may store a number of MP3music files on the memory card 250 using a personal computer (not shownin FIG. 6) and then insert the memory card 250 into a corresponding port251 of the playback system 230. As such, the playback system 230 canretrieve the media content data stored on the memory card in order toplayback the media content to the user. Similar to previously describedembodiments, the playback system 230 includes a connection port 234 thatis configured to receive a cable of an external audio device 231 (FIGS.1-3). Thus, the media content stored on the memory card 250 can bedecoded or otherwise processed (e.g., by one or more components of thecontrol circuitry 240 describe din connection with FIG. 17) so that theplayback system 230 delivers the audio content to the earbuds or otherspeaker instrument of the external audio device 231.

The controller device 200 can include a protective cover 233 that canfit over at least one or the connection port 234 and the memory cardport 251 of the playback system 230. The protective cover 233 isadjustable between an opened position (shown in FIG. 6) and a closedposition in which the connection port 234 and the memory card port 251are covered. The cover 233 may comprise a polymer material that servesto protect ports 234 and 251 from external contaminants when the cover233 is in the closed position. For example, the cover 233 can comprise aflexible elastomers material that fits snugly in a depression over theports 234 and 251, thereby enabling the cover to provide a waterresistant structure over the ports 234 and 251.

Referring now to FIG. 7, some embodiments of the playback system 230 canoperate with a removable data cable 252 that communicates one or moremedia content files from a separate computer system. For example, theuser may store a number of MP3 music files on a personal computer (notshown in FIG. 7), and the user can connect the data cable 252 with acorresponding port 253 of the playback system 230 to transfer some orall of the MP3 files to an internal memory device (refer to memorydevice 246 in FIG. 17). In these circumstances, the user canperiodically update or change the media content that is stored by thepump system and made available through the playback system 230. Theplayback system 230 can retrieve the media content data stored on theinternal memory device in order to playback the media content to theuser. Similar to previously described embodiments, the playback system230 includes a connection port 234 that is configured to receive a cableof an external audio device 231 (FIGS. 1-3). Thus, the media contentstored on the internal memory device can be decoded or otherwiseprocessed so that the playback system 230 delivers the audio content tothe earbuds or other speaker instrument of the external audio device231. Also, in this embodiment, the controller device 200 can include theprotective cover 233 to fit over at least one or the connection port 234and the data cable port 253 of the playback system 230. As previouslydescribed, the protective cover 233 is adjustable between an openedposition and a closed position in which the connection port 234 and thememory card port 251 are covered. The cover 233 may comprise a polymermaterial that serves to protect ports 234 and 251 from externalcontaminants when the cover 233 is in the closed position.

Referring now to FIG. 8, some embodiments of the controller device 200can be configured to receive media content files via a data cableconnection with same electrical connector 218 that is capable of matingwith the pump device 100. For example, the removable data cable 258 cantransmit one or more media content files to the controller device 200from a separate computer system 259. In such circumstances, the user maystore a number of MP3 music files on a separate computer system 259, andthe user can connect the data cable 258 with the electrical connector218 to transfer some or all of the MP3 files to an internal memorydevice of the controller device 200 (refer to memory device 246 in FIG.17). Thus, the user can periodically update or change the media contentthat is stored by the pump system 10 and made available through theplayback system 230. The playback system 230 can retrieve the mediacontent data stored on the internal memory device in order to playbackthe media content to the user via the external audio device 231.

As shown in FIG. 8, the data cable 258 can mate with the electricalconnector 218 when the controller device is separated from the pumpdevice 100. In the depicted embodiment, the controller device 200 isconfigured to be a reusable module that operates with a series ofdisposable pump devices 100 over a period of time. Accordingly after thedata cable 258 transfers the selected media content to the internalmemory of the controller device 200, the data cable 258 can bedisconnected to prepare the controller device 200 for attachment withthe pump device 100. The pump device 100 can be configured to beremovably attached to the controller device 200 in a manner thatprovides a secure fitting, an overall compact size, and a reliableelectrical connection that is resistant to water migration.

In this embodiment, the pump device 100 may be moved in a longitudinaldirection toward the controller device 200 until one or more structuresconnect and secure the separate components in the side-by-sidearrangement. For example, the controller device 200 includes acontroller housing structure 210 having a number of features that areconfigured to mate with complementary features of the pump housingstructure 110 so as to form a releasable mechanical connection. In theembodiment shown in FIG. 8, the pump housing structure 110 includes abarrel 111 that mates with a complementary barrel channel 211 of thecontroller housing 210. Also, the pump housing 110 includes sliderchannel 112 that slidably engages a complementary rail 212 defined bythe controller housing 210. The slider channel 112 can guide therelative motion between the pump device 100 and the controller device200 in the longitudinal direction during the attachment process.Similarly, the pump housing 110 may include a segmented rail 114 a-b(FIG. 1) that mates with a guide channel 214 a-b to direct the relativelongitudinal motion between the pump device 100 and the controllerdevice 200. As described in more detail below, the segmented rails 114a-b may interact with the release member 215 so as to releasably securethe pump device 100 into assembly with the controller device 200. Inaddition, the pump housing 110 may include an extension 113 (FIG. 1)that mates with a depression 213 (FIG. 5) in the controller housing 210when the pump device 100 is fully attached to the controller device 200.

Still referring to FIG. 8, when the pump device 100 is advanced in thelongitudinal direction toward the controller device 200 as guided by theslider channel 112 and the segmented rails 114 a-b, the electricalconnector 118 (FIG. 1) of the pump device 100 is directed towardengagement with the mating connector 218 (FIG. 8) of the controllerdevice 200. As the connectors 118 and 218 join together to form theelectrical connection, the release member 215 is shifted to a positionbetween the segmented rails 114 a-b so as to prevent withdrawal of theconnection. Also, when the connectors 118 and 218 are mated, theextension 113 and barrel 111 are mated with the corresponding depression213 and barrel channel 211 so as to resist relative rotational movementbetween the pump device 100 and the controller device 200. In thisembodiment, the physical attachment of the electrical connectors 118 and218 may also serve to resist relative rotational movement between thepump device 100 and the controller device 200. Furthermore, when theconnectors 118 and 218 are mated, the slide channel 112 is mated withthe corresponding rail 112 and barrel channel 211 so as to resistrelative side-to-side movement between the pump device 100 and thecontroller device 200.

Also, when the connectors 118 and 218 join together to form theelectrical connection, the gasket 140 is compressed between the adjacentsurfaces of the pump housing 110 and the controller housing 210. Thegasket 140 may comprise a polymer foam material that is adhered to asurface of either the pump housing 110 or the controller housing 210(e.g., adhered to the pump housing 110 in this embodiment). The gasket140 may be die cut to a selected shape so as to include an aperture forthe electrical connection. Thus, in this embodiment, the gasket 140surrounds the electrical connection when the pump device 100 is securedto the controller device 200. The configuration provides protection fromwater migration to one or both of the electrical connectors 118 and 218.Accordingly, in particular circumstances, the infusion pump system 10can be assembled into a “water tight” configuration that protectssensitive internal components from water migration in the event that theuser encounters water while wearing the pump system 10.

Accordingly, the pump device 100 is configured to removably attach tothe controller device 200 in a manner that provides a secure fitting, anoverall compact size, and a reliable electrical connection. When thepump device 100 and the controller device 200 are arranged in thisside-by-side configuration, the controller device 200 can beelectrically connected with the pump device 100 while the controllerdevice 200 remains outside of the pump housing 110 (and, likewise, thepump device 100 remains outside of the controller housing 210). As such,the overall size of the assembled system 10 can be minimized, therebyproviding an infusion pump system 10 having a discrete size and enhancedportability.

Additionally, in some embodiments, the attachment of the pump device 100to the controller device 200 can be accomplished by a user with aconvenient “one-movement” process. For example, as previously described,the user can readily slide the pump device 100 and the controller device200 toward one another in a single movement (e.g., in the longitudinaldirection) that causes both a physical connection and an electricalconnection. As described in more detail below in connection with FIGS.11-16, the release member 215 may be arranged so as to automaticallyadjust to a locked position when the pump device 100 is advanced intoengagement with the controller device 200. Thus, the infusion pumpsystem 10 permits users to readily join the pump device 100 and thecontroller device 200 without compound or otherwise difficult handmovements—a feature that can be beneficial to child users or to elderlyusers.

It should be understood that, in other embodiments, other features orconnector devices can be used to facilitate the side-by-side mountingarrangement. These other features or connector devices may include, forexample, magnetic attachment device, mating tongues and grooves,mounting protrusions that friction fit into mating cavities, or thelike.

Referring now to FIG. 9-10, a user can conveniently wear the infusionpump system 10 on the user's skin (e.g., skin adhesive) underneath theuser's clothing or carry the pump device 100 in the user's pocket (orother portable location) while receiving both the medicine dispensedfrom the pump device 100 and the media content from the playback system230. As previously described, in some embodiments the user can receivethe media content via an audio cable of an external audio device 231(FIG. 9), and in alternative embodiments the user can receive the mediacontent via a wireless link to an earpiece device 235′ (FIG. 10).

Referring to FIG. 9, in some embodiments, the infusion pump system 10 ispocket-sized so that the pump device 100 and controller device 200 canbe worn in the user's pocket 6 or in another portion of the user'sclothing. For example, the pump device 100 and the controller device 200can be attached together and form the system 10 that comfortably fitsinto a user's pocket 6. The user can carry the portable infusion pumpsystem 10 and use the tube 147 of the infusion set 146 to direct thedispensed medicine to the desired infusion site. In some circumstances,the user may desire to wear the pump system 10 in a more discretemanner. Accordingly, the user may pass the tube 147 from the pocket 6,under the user's clothing, and to the infusion site where the adhesivepatch 148 is positioned. As such, the pump system 10 can be used todelivery medicine to the tissues or vasculature of the user in aportable, concealable, and discrete manner. Moreover, the pump system 10in this embodiment includes the external audio device 231 having earbuds235 that connect to the controller device 200 via the audio cable. Inthis embodiment, the audio cable of the external audio device 231 canextend out of the user's pocket 6 along the outside of the user'sclothing. As such, the user can readily insert and remove the earbudsdepending upon the user's preference at that particular time.

Referring to FIG. 10, in other embodiments, the infusion pump system 10may be configured to adhere to the user's skin 7 directly at thelocation in which the skin is penetrated for medicine infusion. Forexample, a rear surface 102 (FIG. 3) of the pump device 100 may includea skin adhesive patch so that the pump device 100 is physically adheredto the skin of the user at a particular location. In these embodiments,the cap device 130 may have a configuration in which medicine passesdirectly from the cap device 130 into an infusion cannula 149 that ispenetrated into the user's skin. In one example, the fluid output port139 through the cap device 130 can include a curve or a 90° corner sothat the medicine flow path extends longitudinally out of the medicinecartridge and thereafter laterally toward the patient's skin 7. Again,if the user desires to monitor the operation of the pump device 100 orto adjust the settings of the infusion pump system 10, the user canreadily access the user interface 220 of the controller device 200without the need for carrying and operating a second, separate device.For example, the user may look toward the pump device 100 to view theuser interface 220 of the controller device 200 that is removablyattached thereto. In another example, the user can temporarily detachthe controller device 200 (while the pump device 100 remains adhered tothe skin 7) so as to view and interact with the user interface 220.

In the embodiments in which the pump system 10 is adhered to the user'sskin under his or her clothing, the playback system 230 can include awireless communication link to the earpiece device 235′ (previouslydescribed in connection with FIG. 5). As such, the user can listen tomusic or other audio content stored in the pump system 10 without anaudio cable that extends under his or her clothing to the pump system10. Also, in some embodiments, the user can operate a remote controldevice 260 to control the playback of media content through the playbacksystem 230. The remote control device 260 can be a portable module thatfits in the user's hand or pocket. In this embodiment, the remotecontrol device 260 includes a display screen and a plurality of buttons.The display screen can be used to indicate the media content information226 (FIG. 1) related to the selected media content that is currentlyplaying. The user can actuate the buttons of the remote control 260 towirelessly control the playback of the media content stored in the pumpsystem 10 (and output to the user via the playback system 230). Forexample, the user can operate the remote control device 260 to select adifferent song, adjust the playback volume, pause or resume theplayback, and other such operations. Again, the remote control device260 can be implemented in the embodiments in which the pump system 10 isadhered to the user's skin so that the user can control the playback ofmusic or other audio content stored in the pump system 10 under his orher clothing.

Referring now to FIGS. 11-16, the infusion pump system 10 can beoperated such that the pump device 100 is a disposable, non-reusablecomponent while the controller device 200 is a reusable component. Inthese circumstances, the pump device 100 may be configured as a“one-time-use” device that is discarded after the medicine cartridge isemptied, expired, or otherwise exhausted. Thus, in some embodiments, thepump device 100 may be designed to have an expected operational life ofabout 1 day to about 30 days, about 1 day to about 20 days, about 1 toabout 14 days, or about 1 day to about 7 days—depending on the volume ofmedicine in the cartridge 120, the dispensation patterns that areselected for the individual user, and other factors. For example, insome embodiments, the medicine cartridge 120 containing insulin may havean expected usage life about 7 days after the cartridge is removed froma refrigerated state and the septum 121 is punctured. In somecircumstances, the dispensation pattern selected by the user can causethe insulin to be emptied from the medicine cartridge 120 before the7-day period. If the insulin is not emptied from the medicine cartridge120 after the 7-day period, the remaining insulin may become expiredsometime thereafter. In either case, the pump device 100 and themedicine cartridge 120 therein can be discarded after exhaustion of themedicine cartridge 120 (e.g., after being emptied, expired, or otherwisenot available for use).

The controller device 200, however, may be reused with subsequent newpump devices 100′ and new medicine cartridges 120′. As such, the controlcircuitry, the user interface components, and other components that mayhave relatively higher manufacturing costs can be reused over a longerperiod of time. For example, in some embodiments, the controller device200 may be designed to have an expected operational life of about 1 yearto about 7 years, about 2 years to about 6 years, or about 3 years toabout 5 years—depending on a number of factors including the usageconditions for the individual user. Accordingly, the user is permittedto reuse the controller device 200 (which may include complex orvaluable electronics) while disposing of the relatively low-cost pumpdevice 100 after each use. Such a pump system 10 can provide enhanceduser safety as a new pump device 100′ (and drive system therein) isemployed with each new fluid cartridge 120.

Referring to FIGS. 11-12, the pump device 100 can be readily removedfrom the controller device 200 when the medicine cartridge 120 isexhausted. As previously described, the medicine cartridge 120 isinserted into the cavity 116 (FIG. 1) of the pump housing 110 where itis retained by the cap device 130. In some embodiments, a portion of thepump housing 110 can comprise a transparent or translucent material sothat at least a portion of the medicine cartridge 120 is viewabletherethrough. For example, the user may want to visually inspect themedicine cartridge when the plunger 125 is approaching the output end122 of the medicine cartridge, thereby providing a visual indicationthat the medicine cartridge may be emptied in the near future. In thisembodiment, the barrel 111 of the pump housing 110 comprises a generallytransparent polymer material so that the user can view the medicinecartridge 120 to determine if the plunger 125 is nearing the end of itstravel length. Optionally, some embodiments of the pump device 100 mayinclude a label 117 a that is adhered around the barrel 111. The label117 a may provide a convenient location for basic user instructions,product identification information, and other information related to theinfusion pump system 10. To provide enhanced viewability of the medicinecartridge 120 through the label 117 a, the label 117 a may include awindow 117 b through which the user may visually inspect if the plunger125 is nearing the end of its travel length.

As shown in FIG. 11, the pump device 100 has been used to a point atwhich the medicine cartridge 120 is exhausted. The plunger 125 has beenadvanced, toward the left in FIG. 11, over a period of time so that allor most of the medicine has been dispensed from the cartridge 120. Insome embodiments, the controller device 200 may provide a visual oraudible alert when this occurs so as to remind the user that a newmedicine cartridge is needed. In addition or in the alternative, theuser may visually inspect the medicine cartridge 120 through the barrel111 of the pump housing 110 (and through the window 117 b of the label117 a in this embodiment) to determine if the medicine cartridge 120 isalmost empty. When the user determines that a new medicine cartridge 120should be employed, the pump device 100 can be readily separated fromthe controller device 200 by actuating the release member 215. In thisembodiment, the release member 215 is a latch on the controller device200 that is biased toward a locking position to engage the pump device100. The latch 215 may be arranged to engage one or more features on alateral side of the pump housing 110. As such, the user may actuate therelease member 215 by moving the release member 215 in a lateraldirection 216 (FIG. 11) away from the pump device 100 (e.g., by applyinga force with the user's finger).

As shown in FIG. 12, when the release member 215 is actuated and movedto a position away from the pump device 100, the segmented guide rail114 a-b is free to slide longitudinally in the guide channel 214 a-bwithout interference from the release member 215. Accordingly, the usercan move the pump device 100 in a longitudinal direction 217 away fromthe controller device 200. For example, the segmented guide rail 114 a-bmay slide along the guide channel 214 a-b, the extension 113 (FIG. 1)may be withdrawn from the mating depression 213 (FIG. 12), and theelectrical connector 118 can be separated from the mating connector 218.In these circumstances, the pump device 100 is physically andelectrically disconnected from the controller device 200 while the pumpdevice retains the exhausted medicine cartridge 120.

In some embodiments, the gasket 140 compressed between the pump device100 and the controller device 200 may comprise a resilient material. Insuch circumstances, the gasket 140 can provide a spring-action thaturges the pump device 100 to shift a small amount away from thecontroller device 200 when the release member 215 is moved to theunlocked position (e.g., move in the lateral direction 216 in theembodiment shown in FIG. 11). Accordingly, in some embodiments, the pumpdevice 100 can automatically and sharply move a small distance (e.g.,about 0.5 mm to about 5 mm) away from the controller 200 when therelease member 215 is moved to the unlocked position. Such an automaticseparation provides a convenient start for the user to detach the pumpdevice 100 away from the controller device 200. Furthermore, thisautomatic separation caused by the spring-action of the gasket 140 canprovide a swift disconnect between the electrical connectors 118 and 218when the pump device 100 is being replaced.

Referring to FIGS. 13-14, the same controller device 200 can be reusedwith a new pump device 100′ having a new medicine cartridge 120′retained therein, and the previously used pump device 100 can bediscarded with the exhausted medicine cartridge 120. The new pump device100′ (FIG. 13) can have a similar appearance, form factor, and operationas the previously used pump device 100 (FIGS. 11-12 and 14), and thusthe new pump device 100′ can be readily attached to the controllerdevice 200 for controlled dispensation of medicine from the new medicinecartridge 120′. In some embodiments, the user may prepare the new pumpdevice 100 for use with the controller device 200. For example, the usermay insert the new medicine cartridge 120′ in the cavity 116 of the newpump device 100′ and then join the cap device 130 to the pump housing toretain the new medicine cartridge 120′ therein (refer, for example, toFIG. 1). Although the tubing 147 of the infusion set 146 is not shown inFIG. 13, it should be understood that the tubing 147 may be attached tothe cap device 130 prior to the cap device 130 being joined with thehousing 110. For example, a new infusion set 146 can be connected to thecap device 130 so that the tubing 147 can be primed (e.g., a selectedfunction of the pump device 100 controlled by the controller 200) beforeattaching the infusion set patch to the user's skin. As shown in FIG.13, the new medicine cartridge 120′ may be filled with medicine suchthat the plunger 125 is not viewable through the barrel 111.

As shown in FIG. 14, the previously used pump device 100 that wasseparated from the controller device (as described in connection withFIGS. 11-12) may be discarded after a single use. In thesecircumstances, the pump device 100 may be configured as a disposable“one-time-use” device that is discarded by the user after the medicinecartridge 120 is emptied, is expired, has ended its useful life, or isotherwise exhausted. For example, the pump device 100 may be discardedinto a bin 20, which may include a trash bin or a bin specificallydesignated for discarded medical products. Thus, the user is permittedto dispose of the relatively low-cost pump device 100 after each usewhile reusing the controller device 200 (which may include complex orvaluable electronics) with subsequent new pumps 100′. Also, in somecircumstances, the infusion set 146 (not shown in FIG. 14, refer to FIG.8) that was used with the pump device 100 may be removed from the userand discarded into the bin 20 along with the pump device 100.Alternatively, the infusion set 146 can be disconnected from theprevious pump device 100 and attached to the new pump device 100′. Inthese circumstances, the user may detach the infusion set cannula andpatch from the skin so as to “re-prime” the tubing with medicine fromthe new pump device 100′ to remove air pockets from the tubing.Thereafter, the infusion set cannula and patch can be again secured tothe user's skin.

Referring to FIGS. 15-16, the new pump device 100′ can be removablyattached to the controller device 200 to assemble into the infusion pumpsystem 10 for delivery of medicine to the user. Before the pump device100 is electrically connected with the controller device 200, the usermay prepare the new pump device 100′ for use by pulling the removabletab 141 away from the pump housing 110. In this embodiment, the new pumpdevice 100′ includes the removable tab 141 to seal the battery in theunused pump device 100′ and thereby maintain the battery in a storagemode (refer, for example, to FIG. 14 in which the removable tab 141 isarranged to cover an internal face of a vent 145). The vent 145 can beimplemented in some embodiments of the infusion pump system 10 having apower source arranged that draws upon surrounding air for optimumoperation. Because the controller device 200 and the pump device 100 maybe sealed to resist water migration during normal usage, thewater-resistant vent instrument 145 may be used to provide the air tothe power source without permitting migration of water therethrough. Forexample, in this embodiment, the pump device 100 may house a powersource 345 in the form of a zinc-air cell battery (refer to FIG. 18),which draws upon the surrounding air during operation. When the pumpdevice 100 is in use, the pump housing 110 is preferably sealed toprotect the internal drive system and medicine cartridge from watermigration. As such, the pump housing 110 may include the water-resistantvent 145 disposed proximate to the zinc-air cell battery 345 so thatsome air may pass through the vent 145 and toward the battery. Thewater-resistant vent instrument 145 may include one or more layers of amaterial that is permeable to air and resistant to passage of liquidssuch as water. For example, the water-resistant vent instrument 145 mayinclude one or more layers of a GORE-TEX material to resist themigration of water into the pump device while permitting the passage ofair toward the battery.

As described in more detail below, when the new pump device 100′ isprepared for usage, the removable tab 141 can be pulled away from thepump housing 110 (and away from the battery therein), which switches thebattery into an activation mode. Thus, the shelf-life of the pump device100′ (prior to usage with the controller device 200) may be extended bysealing the battery in a storage mode because little, if any, energy isdissipated from the battery when in the storage mode.

The new pump device 100′ can be connected to the controller device 200by advancing the new pump device 100′ in a longitudinal direction 219(FIG. 15) toward the controller device 200. When the pump device 100′ isadvanced in the longitudinal direction 219 toward the controller device200, the movement is guided by the slider channel 112 (FIG. 8) and thesegmented rails 114 a-b. In particular, the slider channel 112 of thepump housing engages the rail 212 of the controller housing 210. Also,the front portion of the segmented rail 114 a slides into the rearportion of the guide channel 214 b. In this embodiment, the frontportion of the segmented rail 114 a includes a ramp surface 114 c (referalso to FIG. 1) that engages a complementary ramp surface 215 c (FIG. 8)of the release member 215 to thereby force the release member 215 awayfrom the guide channel 214 a-b during advancement of the pump device100′. The release member 215 is temporarily forced away from the guidechannel 214 a-b so that the front portion of the segmented rail 114 apasses over the release member 215, which enables the electricalconnector 118 of the pump device 100′ to engage with the matingconnector 218 of the controller device 200. As the connectors 118 and218 join together to form the electrical connection, the release member215 biased to return to its latched position and is shifted to aposition in the guide channel 214 a-b between the segmented rails 114a-b so as to prevent withdrawal of the pump device 100′.

As previously described, the guided motion in the longitudinal direction219 provides the user with a convenient “one-movement” process to attachthe pump device 100′ and the controller device 200. For example, theuser can readily slide the pump device 100′ and the controller device200 toward one another in a single movement (e.g., in the longitudinaldirection) that causes both a physical connection and an electricalconnection. Thus, the infusion pump system 10 permits users to readilyjoin the pump device 100′ and the controller device 200 without compoundor otherwise difficult hand movements—a feature that can be beneficialto child users or to elderly users.

As shown in FIG. 16, when the new pump device 100′ is fully advanced andattached to the controller device 200, the gasket 140 is compressedbetween the opposing surfaces of the pump housing 110 and the controllerhousing 210. Such a configuration provides a water-resistance sealaround the electrical connection that protects the sensitive internalcomponents of the pump device 100′ and the controller device 200 fromdamage or malfunction.

As previously described in connection with FIGS. 2-3, the tubing 147 ofthe infusion set 146 can be attached to the cap device 130 to provide afluid path from the new pump device 100′ to the user. Likewise, theexternal audio device 231 of the playback system 230 can be connected tothe controller device 200 so as to deliver selected media content to theuser.

In some embodiments, the playback system 230 can be configured toprovide tutorial content or voice instructions to the user during theprocess previously described in connection with FIGS. 11-16. Forexample, when the user is going to detach the controller device 200 anddiscard an exhausted pump device 100 (as previously described), the usercan activate the playback system 230 to output voice instructionsthrough the external audio device 231 that guides the user on thedetachment operations. Furthermore, the voice instructions can guide theuser through the operations of preparing a new pump device 100′ andremovably attaching the new pump device 100′ to the controller device200 in a manner that provides a secure fitting, an overall compact size,and a reliable electrical connection.

Referring now to FIG. 17, the controller device 200 (shown in anexploded view) houses a number of components that can be reused with aseries of successive pump devices 100. In particular, the controllerdevice 200 includes control circuitry 240 arranged in the controllerhousing 210 that is configured to communicate control signals to thedrive system of the pump device 100. In this embodiment, the controlcircuitry 240 includes a main processor board 242 that is incommunication with a power supply board 244. The control circuitry 240includes at least one processor 243 that coordinates the electricalcommunication to and from the controller device 200 (e.g., communicationbetween the controller device 200 and the pump device 100). Theprocessor 243 can be arranged on the main processor board 242 along witha number of other electrical components such as at least one memorydevice 246. It should be understood that, although the main processorboard 242 is depicted as a printed circuit board, the main processorboard can have other forms, including multiple boards, a flexiblecircuit substrate, and other configurations that permit the processor243 to operate. The control circuitry 240 can be programmable in thatthe user may provide one or more instructions to adjust a number ofsettings for the operation of the infusion pump system 10. Such settingsmay be stored in the memory device 246 arranged in the control circuitry240. Furthermore, in some embodiments the memory device 246 can storeexecutable software instructions for the processor 243. Alternatively,the control circuitry 240 may include other dedicated memory devices(e.g., separate from the memory device 246) that store executablesoftware instructions for the processor 243. The control circuitry 240may include other components, such as sensors, that are electricallyconnected to the main processor board 242. For example, at least aportion of an occlusion sensor system (not shown in FIG. 17) can beelectrically connected to the main processor board 242 via a flexiblecircuit substrate or one or more wires.

As previously described, the controller device 200 can be electricallyconnected with the pump device 100 via mating connectors 118 and 218(FIGS. 1 and 8) so that the control circuitry 240 can communicatecontrol signals to the pump device 100 and receive feedback signals fromcomponents housed in the pump device 100. In this embodiment, theelectrical connector 118 (FIG. 1) on the pump device 100 is a z-axisconnector, and the connector 218 (FIG. 8) on the controller device 200is adapted to mate therewith. The electrical connector 218 on thecontroller device 200 is in communication with the control circuitry240. As such, the processor 243 can operate according to softwareinstructions stored in the memory device 246 so as to send controlsignals to the pump device 100 via the connector 218.

The memory device 246 connected to the control circuitry 240 can beconfigured to store media content for use by the playback system 230.For example, the memory device 246 can electronically store a number ofMP3 music files or other audio content data for subsequent playback tothe user via the earbuds of external audio device 231. In someembodiments, the memory device 246 can include a first memory portion247 a that stores media content files, such as music, audiobooks,interactive games, images and other video data, or the like. The firstmemory portion 246 a can be made available for updating or otherwisechanging the media content files in accordance with the user'sselections. In addition, the first memory portion 246 a can includeother information related to the media content stored therein, includingtitle and artist/author information, playback history information,licensing and authorization information, playlist information, or thelike.

The memory device 246 may also include a second memory portion 247 bthat is dedicated to storing infusion pump data, such as pump settingsand menu options, basal and bolus dispensation data, executable softwareinstructions (for the processor 243) that control the operation of thepump device 100, and the like. The second memory portion 247 b can beselected to provide ample storage space for the infusion pump data sothat the pump device 100 can safely dispense the medicine in accordancewith the signals from the properly operating control device 200. Inparticular embodiments, the second memory portion 247 b may bepartitioned or segregated the first memory portion 247 a or otherwiseprotected from overwriting during the process of updating or changingthe media content files stored in the first memory portion 247 a. Inalternative embodiments, the memory device 246 may comprise a pluralityof separate memory cards or memory chips accessible to the processor243, some of which are dedicated to the media content data and othersthat are dedicated to the infusion pump data.

Still referring to FIG. 17, the playback system 230 can include an audiojack 232 or other media device output (e.g., wireless transmitter 231′for outputting media content data to the earpiece 235′ shown in FIG. 5)that is electrically connected to the control circuitry 240. As such,the processor 243 can execute a media player software program stored inthe memory device 246 so as to decode or otherwise retrieve one or moremedia content files and output signals via the audio jack 232. Thesignals output from the audio jack 232 can include audio signals thatcause the external audio device 231 to generate audible soundsindicative of the selected media content (e.g., song, audiobook, voiceinstructions, or the like). In this embodiment, the audio jack 232comprises a connector that mates with a plug end of the external audiodevice 231. The audio jack 232 can be arranged in the controller housing210 so that it is generally aligned with the port 234 that receives theplug end of the external audio device 231.

Still referring to FIG. 17, the user interface 220 of the controllerdevice 200 can include input components, output components, or both thatare electrically connected to the control circuitry 240. For example, inthis embodiment, the user interface 220 includes the display device 222having an active area that outputs information to a user and fourbuttons 224 a-d that receive input from the user. Here, the display 222may be used to communicate a number of settings or menu options for theinfusion pump system 10. In this embodiment, the control circuitry 240may receive the input commands from the user's button selections andthereby cause the display device 222 to output a number of menus orprogram screens that show particular settings and data (e.g., reviewdata that shows the medicine dispensing rate, the total amount ofmedicine dispensed in a given time period, the amount of medicinescheduled to be dispensed at a particular time or date, the approximateamount of medicine remaining the cartridge 120, or the like). Aspreviously described, the controller circuit 240 can be programmable inthat the input commands from the button selections can cause thecontroller circuit 240 to change any one of a number of settings for theinfusion pump system 10. In addition, the display 222 may be used toshow the media content information 226 (FIG. 1) related to selectedmedia content loaded by the playback system 230. Again, the controlcircuitry 240 may receive the input commands from the user's buttonselections and thereby cause the display device 222 to output a numberof playlists, menus, or program screens that show media content settingsand data (e.g., titles, artists, customized playlists, usage or playbackstatistics, or the like). As previously described, the controllercircuit 240 can be programmable in that the input commands from thebutton selections can cause the controller circuit 240 to change any oneof a number of media content settings.

As previously described in connection with FIGS. 7 and 8, someembodiments of the pump system 10 include a cable connector (e.g., adata cable port or a data cable that mates with connector 218) forcommunicating with a separate computer system. As such, the data cablemay electrically connect to the control circuitry 240 to upload data orprogram settings to the controller circuit or to download data from thecontrol circuitry 240. For example, historical data of medicine deliverycan be downloaded from the control circuitry 240 (via the cableconnector) to a computer system of a physician or a user for purposes ofanalysis and program adjustments. Optionally, the data cable may alsoprovide recharging power.

Still referring to FIG. 17, the control circuitry 240 of the controllerdevice 200 may include a second power source 245 that can receiveelectrical energy from a first power source 345 (FIG. 18) housed in thepump device 100. In this embodiment, the second power source 245 iscoupled to the power supply board 244 of the control circuitry 240. Thehard-wired transmission of the electrical energy can occur through thepreviously described connectors 118 and 218 (FIGS. 1 and 8). In suchcircumstances, the first power source 345 (FIG. 18) may include a highdensity battery that is capable of providing a relatively large amountof electrical energy for its package size, while the second power source245 (FIG. 17) may include a high current-output battery that is capabledischarging a brief current burst to power the drive system 300 of thepump device 100. Accordingly, the first battery 345 disposed in the pumpdevice 100 can be used to deliver electrical energy over time (e.g.,“trickle charge”) to the second battery 245 when the controller device200 is removably attached to the pump device 100. For example, aspreviously described, the first battery 345 may comprise a zinc-air cellbattery. The zinc-air cell battery 345 may have a large volumetricenergy density compared to some other battery types. For example, thezinc-air cell battery 345 may have a volumetric energy density ofgreater than about 900 Watt-hours/Liter (Wh/L), about 1000 Wh/L to about1700 Wh/L, and about 1200 Wh/L to about 1600 Wh/L. Also, the zinc-aircell battery may have a long storage life, especially in thoseembodiments in which the battery is sealed (e.g., by the removable tab141 or the like) during storage and before activation. One exemplaryzinc-air cell battery provides a potential voltage of about 1.1V toabout 1.6V (about 1.2V to about 1.4 V, and about 1.3 V in oneembodiment), a current output of about 8 mA to about 12 mA (about 10 mAin one embodiment), and a storage capacity of greater than about 600mA·h (about 650 mA·h in one embodiment).

As shown in FIG. 17, the second battery 245 may include a highcurrent-output device that is housed inside the controller housing 210.The second battery 245 can be charged over a period of time by the firstbattery 345 and then intermittently deliver high-current bursts to thedrive system 300 over a brief moment of time. In addition, the secondbattery 245 can be used to power the playback system 230 so that theselected media content (stored in the memory device 246) is delivered tothe user (e.g., via the external audio device 231 in this embodiment).For example, the second battery 245 may comprise a lithium-polymerbattery. The lithium polymer battery disposed in the controller device200 may have an initial current output that is greater than the zinc-aircell battery disposed in the pump device 100, but zinc-air cell batterymay have an energy density that is greater than the lithium polymerbattery (e.g., the lithium polymer battery disposed in the controllerdevice 200 may have a volumetric energy density of less than about 600Wh/L). In addition, the lithium-polymer battery 245 is readilyrechargeable, which permits the zinc-air battery 345 disposed in thepump device 100 to provide electrical energy to the lithium-polymerbattery 245 for purposes of recharging. One exemplary lithium-polymerbattery provides a initial current output of about greater than 80 mA(about 90 mA to about 110 mA, and about 100 mA in one embodiment) and amaximum potential voltage of about 4.0V to and 4.4V (about 4.2 V in oneembodiment). In other embodiments, it should be understood that thesecond power source 245 may comprise a capacitor device capable of beingrecharged over time and intermittently discharging a current burst toactivate the drive system 300.

Accordingly, the infusion pump system 10 having two power sources 345and 245—one arranged in the pump device 100 and another arranged in thereusable controller device 200—permits a user to continually operate thecontroller device 200 without having to recharge a battery via awall-plug or other cable. Because the controller device 200 can bereusable with a number of pump devices 100 (e.g., attach the new pumpdevice 100′ after the previous pump device 100 is expended anddisposed), the second power source 245 in the controller device can berecharged over a period of time each time a new pump device 100 isconnected thereto. Such a configuration can be advantageous in thoseembodiments in which the pump device 100 is configured to be adisposable, one-time-use device that attaches to a reusable controllerdevice 200. For example, in those embodiments, the “disposable” pumpdevices 100 recharge the second power source 245 in the “reusable”controller device 200, thereby reducing (or possibly eliminating) theneed for separate recharging of the controller device 200 via a powercord plugged into a wall outlet.

In particular embodiments, the activation of the media content playbacksystem 230 may be limited if the controller device 200 detects that theremaining capacity of the power source (e.g., battery 245 in thisembodiment) reaches below a threshold level. In such circumstances, theremaining battery power can be automatically reserved for use inoperating the drive system 300 to deliver medicine to the user.Alternatively, the playback system 230 may be limited by the controllerdevice 200 based on a power use profile. The power use profile canprovide an estimate of remaining battery life based on the user'sactivity with the infusion pump system 10 (e.g., activations of thedrive system to provide basal and bolus dispensations, historicalinteraction with the user interface 220, history of activating theplayback system 230, and the like). Using this power use profile, thecontroller device 200 can estimate how long the remaining battery powerwill last in order to dispense the medicine remaining in the cartridge120. If the power use profile indicates that the remaining battery powermay be insufficient, particular features such as the playback system 230may be limited or shut off in order to conserve the remaining batterypower for activating drive system and indicating alarms. In anotherexample, the controller device 200 may limit the number of uses of theplayback system 230 to a predetermined amount of usage (e.g., totaloutput time or the like) per day or per attachment of a new pump device100. Again, providing a limit on the usage of playback system 230 canconserve the battery power for other operations such as alarmindications and the drive system.

Referring now to FIG. 18, the pump device 100 may include a drive system300 that is controlled by the removable controller device 200 (FIGS. 1-3and 8). Accordingly, the drive system 300 can accurately andincrementally dispense fluid from the pump device 100 in a controlledmanner. The drive system 300 may include a flexible piston rod 370 thatis incrementally advanced toward the medicine cartridge 120 so as todispense the medicine from the pump device 100. At least a portion ofthe drive system 300 is mounted, in this embodiment, to the pump housing110. In this embodiment, the pump housing 110 includes a chassis 107that is at least partially covered by a shell portion (removed from FIG.18 for purposes of illustrating the drive system 300). The shell portioncan be used to cover at least a portion of the drive system 300. Theshell portion can slide over and join with the chassis 107 (and otherbody portions) to form the assembled pump housing 110.

Some embodiments of the drive system 300 may include a battery poweredactuator (e.g., reversible motor 320 or the like) that resets a ratchetmechanism 330, a spring device 350 (FIG. 22) that provides the drivingforce to the ratchet mechanism 330, and a drive wheel 360 that isrotated by the ratchet mechanism 330 to advance the flexible piston rod370 toward the medicine cartridge 120. Also, the pump device 100 caninclude one or more motion detectors coupled with the drive system 300to provide feedback regarding the operation of the drive system 300. Forexample, the pump device 100 may include a first motion detector 302configured as a limit switch that detects when a portion of the ratchetmechanism 330 has reached the limit of its travel and must thereafterstop movement or reverse direction. In another example, the pump device100 may include a second motion detector 307 in the form of a mechanicalerror switch that indicates whether components of the drive system 300completed the desired motion for each drive cycle.

Still referring to FIG. 18, the pump device 100 includes a connectorcircuit 310 to facilitate the transfer of signals to and from theelectrical connector 118 (FIG. 1). As previously described, theelectrical connector 118 of the pump device 100 mates with the connector218 (FIG. 8) of the controller device 200 so that electricalcommunication can occur between the pump device 100 and the controllerdevice 200. The connector circuit 310 may comprise a generallynon-complex circuit 310 that does not include a processor or otherrelatively high-cost components. In this embodiment, the connectorcircuit 310 operates as a passageway for the control signals (from thecontrol circuitry 240 (FIG. 17) of the controller device 200) totransmit to the drive system 300 (e.g., to the actuator 320). Forexample, the reversible motor 320 may be connected to the connectorcircuit 310 via one or more wires 304. The connector circuit 310 alsooperates as a passageway for the electrical power from the first battery345 (FIG. 18) to pass to the controller device 200 for recharging of thesecond battery 245 (FIG. 17). For example, the first battery 345 may beconnected to the connector circuit 310 via one or more power contacts305. Furthermore, the connector circuit 310 operates as a passageway forfeedback signals (e.g., from the motion detectors 302 and 307) totransmit to the control circuitry 240 (FIG. 17) of the controller device200. For example, the limit switch 302 may be connected to the connectorcircuit 310 via one or more wires 306 (the one or more wires connectingthe mechanical error switch 307 to the connector circuit 310 are notshown in FIG. 18).

In some embodiments, the connector circuit 310 in the pump device 100includes a memory device 318 that can store data regarding the pumpdevice 100 and its operational history. For example, the memory device318 of the connector circuit 310 may include a flash memory chip that isconfigured to store data such as: a unique serial number designated forthe pump device 100, a manufacturer identifier code, and a drive cyclecounter. The unique serial number designated for the pump device 100 andthe manufacturer identifier code may be useful pieces of quality controlinformation that remains with the pump device 100 throughout itsshelf-life and operational life. If, for example, a manufacturing erroris identified for a particular pump device 100, the unique serial numberand the manufacturer identifier code (e.g., a lot code) can be used topromptly identify the manufacturing location and its manufacturing lot.

The drive cycle counter stored in the memory device 318 can be usefulfor maintaining an accurate estimate of the volume of medicine thatremains in the medicine cartridge 120. For example, the number of drivecycles that are required to incrementally advance the plunger 125 andthereby dispense a full medicine cartridge 120 may be a predeterminedvalue (e.g., in some embodiments, 6,300 drive cycles result in fulldispensation of a new medicine cartridge). Accordingly, the drive cyclecounter stored in the memory device 318 can keep track of the number ofdrive cycles that have occurred through the operational life of the pumpdevice 100. Each time the motor 320 completes a new drive cycle andincrementally advances the piston rod 370 to dispense some medicine, thecontroller device 200 can store an updated value for the drive cyclecounter stored in the memory device 318. When the updated value storedin drive cycle counter stored in the memory device 318 approaches thepredetermined value, the controller device 200 can alert the user thatthe medicine cartridge is approaching exhaustion. Furthermore, becausethe memory device 318 is arranged in the pump device 100, the drivecycle counter stored in the memory device 318 remains local to the pumpdevice 100. If the pump device 100 is temporarily disconnected from thecontroller device 200 and then reconnected (or reconnected to adifferent controller device 200), the controller device 200 can retrievethe value for the drive cycle counter stored in the memory device 318and promptly ascertain how much medicine remains in the medicinecartridge 120.

Still referring to FIG. 18, in some embodiments, the flexible piston rod370 comprises a plurality of segments 372 serially connected by hingeportions 373 so that the flexible piston rod 370 is adjustable from acurved shape to a noncurved shape. The plurality of segments 372 and theinterconnecting hinge portions 373 can be integrally formed in one piecefrom one or more moldable materials, including polymer materials such asNylon or POM. In this embodiment, each of the plurality of rod segments372 includes an exterior thread pattern 374 along at least onecylindrical surface portion. The piston rod 370 also includes a plungerengagement device 375 can be arranged at a forward end of the piston rod370. As such, the plunger engagement device 375 faces toward themedicine cartridge 120 when the medicine cartridge 120 is inserted intothe cavity 116. In some embodiments, the plunger engagement device 375may comprise a pusher disc that abuts against the plunger 125 of themedicine cartridge 120.

Because the flexible piston rod 370 is adjustable from a curved shape toa noncurved shape, the overall length of the pump device can be reducedin some embodiments. For example, in a typical infusion pump that housesa straight and rigid rod, the typical infusion pump requires a packageor housing having a linear dimension sufficient to accommodate thelength of the rigid piston rod when it is at its limit of travel inwhich it is fully withdrawn from the container or cylinder. The pumpdevice 100 incorporating the flexible piston rod 370 can require lessspace than a similar device that houses a non-flexible, rigid rod.

Referring now to FIG. 19, a block diagram of the pump system 10illustrates the operation of some components of the pump device 100 andthe controller device 200. The controller device 200 is removablyattached to the pump device 100 so as to form an electrical connectionbetween connectors 118 and 218 (previously described in FIGS. 1 and 8).The controller device 200 includes the previously described processor243, memory device 246, power source 245, display 222, and keypadbuttons 224 a-d. Such components can be used to control the activationof the pump device 100 so as to dispense a medicine dosage to the user.For example, the processor 243 can execute pump operation instructionsstored in the memory 246 in accordance with the pump settings (some ofwhich can be adjusted by the user with the display 222 and keypadbuttons 224 a-d). As such, the processor 243 can cause an activationsignal to be sent from the controller device 200 to the actuator 320 inthe pump device 100. As previously described, the activation power forthe actuator 320 can be provided from the power source 245 located inthe controller device 200.

In addition, the pump system 10 is a capable of providing media contentplayback while worn by the user and while dispensing medicine to theuser. As shown in FIG. 19, this embodiment of the pump system includesthe audio output 232, which can be an audio jack for connection with anexternal audio device 231 (FIG. 4) or a wireless transmitter forcommunication with the audio earpiece 235′ (FIG. 5). Also, the memory246 housed in the controller device 200 can store a number of mediacontent files. As previously described, the memory 246 can include aselected portion 247 a that is reserved for the storage of media contentfiles. In addition, some embodiments of the pump system 10 include anexternal memory connector. In this embodiment, the external memoryconnector comprises the cable connector 253 for connection via the datacable 252 to a separate computer system, as previously described inconnection with FIG. 7. Alternatively, the external memory connector maycomprise the memory card port 251 for connection to with the removablememory card 250, as previously described in connection with FIG. 6.Accordingly, the pump system 10 can be configured to permit the user toupdate or otherwise change the media content files that are stored inthe memory 246.

Referring now to FIGS. 20A-B, the pump system 10 can be configured togroup a number of media content files into one or more playlists. Inparticular, the user can customize and save a playlist so that theplayback system 230 will thereafter deliver the selected group of mediacontent files when the playlist is activated. As previously described,the user interface 220 of the pump system 10 can include displaynumerals, text, symbols, images, or a combination thereof in order tocommunicate media content information to the user. For example, thedisplay device 222 can be used to communicate a menu option in which theuser can select particular media content file for assignment to acustomized playlist. As shown in FIG. 20A, the display device 222 candisplay a list of media content files (e.g., MP3 music files in thisembodiment) that are stored on the memory device 246 (FIG. 17). In thisembodiment, the user may press the buttons 224 b and 224 c to scrollthrough list of media content files. When the user encounters a song thethat should added to the particular playlist (e.g., “Playlist 1” in thisembodiment), the user can actuate the button 224 d positioned adjacentto the “YES” indicator in the display 222. A similar process can be usedto remove selected media content files from a previously saved playlist.

As shown in FIG. 20B, the user can press one or more of the buttons 224a-d to select menu options for the playback system 230, including anoption to playback a particular playlist (e.g., “Playlist 1” in thisembodiment). As previously described, when the user activates theplayback system 230, the processor 243 can execute a media playersoftware program stored in the memory device 246 so as to decode orotherwise retrieve one or more media content files and output signalsvia the audio jack 232 (refer to FIG. 17). The signals output from theaudio jack 232 can include audio signals that cause the external audiodevice 231 to generate audible sounds indicative of the particular mediacontent organized in the selected playlist. In this embodiment, thedisplay device 222 may include a media content message (e.g., “LoadingPlaylist 1 . . . ” as shown, for example, in FIG. 20B) that indicates tothe user that the media player has been activated to output the mediacontent.

Referring now to FIGS. 21A-B, the media content stored in the memory 246of the pump system 10 can include an instructional content that providesa tutorial on how to operate particular features of the system 10. Suchmedia content can be used to provide training to new users (especiallyfor children or other users that may require additional training outsideof a clinic). In this example, the instructional content can include anaudio tutorial on how to prepare the pump system 10 for medicinedispensation after a new pump device 100 can be connected to thecontroller device 200. As previously described in connection with FIGS.11-16, the controller device can be reused with a new pump device 100′after a previously used pump device is emptied, expired, or otherwiseexhausted. In such embodiments, the controller device 200 can detectwhen the new pump device 100 is connected thereto, and the displaydevice 222 can be used to query whether the user would like to receivethe audio tutorial. As shown in FIG. 21A, the display device 222 canprompt the user to indicate whether the audio tutorial (or otherinstructional content) should be delivered through the playback system230. The user can actuate the button 224 b (adjacent to the “No”indicator) to input that no audio tutorial should be played at thistime. Alternatively, the user can actuate the button 224 c (adjacent tothe “Yes” indicator) to input that the audio tutorial should be started.In some embodiments, the controller device 200 can be configured toautomatically display the query screen 222 (as illustrated in FIG. 21A)for a limited period of time. For example, the query screen 222 (asillustrated in FIG. 21A) may be automatically displayed in response tothe attachment of a new pump device only for a period of one month afterthe controller device 200 is initially activated. Accordingly, as theuser becomes accustom to the operation of the pump system 10 over theperiod of the initial month, the user may no longer need to receive theplayback of the audio tutorial for this particular feature.

As shown in FIG. 21B, when the user indicates that the audio tutorialshould be played, the processor 243 can execute a media player softwareprogram stored in the memory device 246 so as to decode or otherwiseretrieve the selected file containing the instructional content andoutput signals via the audio jack 232 (refer to FIG. 17). The signalsoutput from the audio jack 232 can include audio signals that cause theexternal audio device 231 to generate voice instructions indicative ofthe selected tutorial. For example, the audio tutorial may provide voiceinstructions from the earbuds 235 that explain to the user how to attachthe infusion set tubing 147 (compare FIG. 21A to FIG. 21B) or how toprime the infusion set tubing that was previously attached. The mediacontent stored in the memory 246 of the pump system 10 may include otheraudio tutorials that provide instructions related to, for example,inserting the infusion set into the skin site, setting a new basal rate,setting a time-based basal rate program, activating a bolus dose,calculating a bolus dose based upon food intake, downloading softwareupdates for the controller device 200, uploading historical dispensationdata for review by a physician, periodically inspecting the pump system10, and other actions to be performed by the user.

Referring now to FIGS. 22-24, some embodiments of a portable infusionpump system 400, 500, and 600 having media player capabilities canemploy a reusable pump apparatus (rather than a disposable pump deviceas previously described). In such circumstances, the infusion pumpsystem 400, 500, and 600 may comprise a reusable device that houses thecontrol circuitry and the pump drive system. Similar to previouslydescribed embodiments, the infusion pump system 400, 500, and 600 mayalso include an media content playback system 430, 530, and 630 that canplayback media content to the user contemporaneously with thedispensation of medicine to the user. Accordingly, the user can operatethe reusable pump device so as to receive controlled delivery of amedicine while also listening to the playback of selected MP3 music orother media content. As previously described, the pump system 400, 500,and 600 having the media content playback system 430, 530, and 630 mayprovide a compact, multi-purpose device that eliminates the need for theuser to carry multiple devices (e.g., a medical pump device and aseparate media player device). Also, the infusion pump system 400, 500,and 600 can enhance user safety by interrupting the music content orother media content in order to deliver an alarm to the user that mightotherwise go unnoticed if the user was listening to a separate mediaplayer device.

In the particular embodiment depicted in FIG. 22, the pump system 400comprises a reusable pump device that houses both the controllercircuitry and the pump drive system. Similar to previously describedembodiments, the pump system 400 can include a housing structure thatdefines a cavity in which a medicine cartridge can be received (notshown in FIG. 22; refer for example to cartridge 120 in FIG. 1). Forexample, the pump system 400 can be adapted to receive a medicinecartridge in the form of a carpule that is preloaded with insulin oranother medicine. The pump drive system can act upon the fluid cartridgeto controllably dispense medicine through an infusion set 146 and intothe user's tissue or vasculature. In this embodiment, the user can wearthe portable pump system 400 on the user's skin under clothing or in theuser's pocket while receiving the medicine dispensed through theinfusion set 146.

Still referring to FIG. 22, the infusion pump system 400 may alsoinclude a media content playback system 430 that can playback mediacontent (e.g., music, voice instructions, audiobooks, audio thatcorresponds to a video being displayed, and other data) to the userwhile the pump system 400 is delivering the medicine to the user.Similar to previously described embodiments, the playback system 430 maycomprise an external audio device 431 that plugs into a connection portalong the pump housing so as to mate with an audio output device (e.g.,an audio jack similar to the component 232 shown in FIG. 17). Theexternal audio device 431 may include earbuds 435 or another listeningdevice that deliver sound to the user's ear while the pump system 400 iscarried by the user. At least one memory device arranged in the pumpsystem 400 can be used to electronically store a number of media contentfiles available for playback to the user. Accordingly, the user canoperate a user interface 420 of the infusion pump system 400 so as toreceive controlled delivery of a medicine while also listening to theplayback of selected MP3 music or other media content.

In this embodiment, the user interface 420 includes a display device 422and one or more user-selectable buttons 424 a-e. The display device 422can include an active area in which numerals, text, symbols, images, ora combination thereof can be displayed (as shown, for example, in FIG.22). For example, the display device 422 can be used to communicatemedia content information 426, which may related to the selected mediacontent that is being delivered to the user through the playback system430. Also, the display device 422 can be used to communicate a number ofsettings or menu options for the infusion pump system 400. For example,the display device 422 can be used to communicate medicinal deliveryinformation 427, such as the basal delivery rate (as shown in FIG. 22),a bolus dosage, a historical record of medicine delivered, the amount ofmedicine remaining in the cartridge, or the like. In another example,the display device 422 can be used to communicate time and dateinformation 428, which can be used by the user to determine dosageschedules, bolus delivery times, meal times, or the like.

Accordingly, the user may press one or more of the buttons 424 a, 424 b,424 c, 424 d, and 424 e to shuffle through a number of menus or programscreens that show particular settings and data (e.g., review data thatshows the medicine dispensing rate, the total amount of medicinedispensed in a given time period, the amount of medicine scheduled to bedispensed at a particular time or date, the approximate amount ofmedicine remaining in the cartridge 120, or the like). Also, the usercan adjust the settings or otherwise program the pump system 400 bypressing one or more buttons 424 a, 424 b, 424 c, 424 d, and 424 e ofthe user interface 420. Furthermore, the user can press one or more ofthe buttons 424 a, 424 b, 424 c, 424 d, and 424 e so as to play, pause,rewind, or fast-forward the selected media content 426 or to otherwisecontrol the output of media content through the playback system 430.Thus, the user can contemporaneously monitor the operation of the pumpsystem 400 and control the media content playback from the same userinterface 420. Similar to previously described embodiments, the pumpsystem 400 can be configured to interrupt the music content or othermedia content in order to deliver an alarm via the user's external audiodevice 431 (e.g., earbud device, other headphone device, or the like),thereby enhancing the user safety. Finally, the media content played bythe pump system 400 may include an audio tutorial or other instructionalcontent on how to operate particular features of the system, whichfacilitates new user training.

Referring now to the particular embodiment depicted in FIG. 23, the pumpsystem 500 comprises a reusable pump device that houses both thecontroller circuitry and the pump drive system. Similar to previouslydescribed embodiments, the pump system 500 can include a housingstructure that defines a cavity in which a medicine cartridge can bereceived. For example, the pump system 500 can be adapted to receive amedicine cartridge in the form of a carpule that is preloaded withinsulin or another medicine. The pump drive system can act upon thefluid cartridge to controllably dispense medicine through an infusionset 146 and into the user's tissue or vasculature. Again, the user canwear the portable pump system 500 on the user's skin under clothing orin the user's pocket while receiving the medicine dispensed through theinfusion set 146.

The infusion pump system 500 may also include a media content playbacksystem 530 that can playback media content to the user while the pumpsystem 500 is delivering the medicine to the user. Similar to previouslydescribed embodiments, the playback system 530 may comprise an externalaudio device 531 that plugs into a connection port along the pumphousing so as to mate with an audio output device (e.g., an audio jackor the like). The external audio device 531 may include earbuds 535 oranother listening device that deliver sound to the user's ear while thepump system 500 is carried by the user. At least one memory devicearranged in the pump system 500 can be used to electronically store anumber of media content files available for playback to the user.Accordingly, the user can operate a user interface 520 of the infusionpump system 500 so as to receive controlled delivery of a medicine whilealso listening to the playback of selected MP3 music or other mediacontent.

Still referring to FIG. 23, the user interface 520 includes a displaydevice 522 and one or more user-selectable buttons 524 a-c. The displaydevice 522 can include an active area in which numerals, text, symbols,images, or a combination thereof can be displayed. For example, thedisplay device 522 can be used to communicate media content information526, which may related to the selected media content that is beingdelivered to the user through the playback system 530. Also, the displaydevice 522 can be used to communicate a number of settings or menuoptions for the infusion pump system 500. For example, the displaydevice 522 can be used to communicate medicinal delivery information527, such as the basal delivery rate (as shown in FIG. 23) or the like.In another example, the display device 522 can be used to communicatetime and date information 528. Similar to previously describedembodiments, the user may press one or more of the buttons 524 a, 524 b,and 524 c to shuffle through a number of menus or program screens thatshow particular settings and data related to the medicine dispensation.Also, the user can adjust the settings or otherwise program the pumpsystem 500 by pressing one or more buttons 524 a, 524 b, and 524 c ofthe user interface 520. Furthermore, the user can press one or more ofthe buttons 524 a, 524 b, and 524 c so as to play, pause, rewind, orfast-forward the selected media content 526 or to otherwise control theoutput of media content through the playback system 530. Accordingly,the user can contemporaneously monitor the operation of the pump system500 and control the media content playback from the same user interface520. Similar to previously described embodiments, the pump system 500can be configured to interrupt the music content or other media contentin order to deliver an alarm via the user's external audio device 531,thereby enhancing the user safety. Also, the media content played by thepump system 500 may include an audio tutorial or other instructionalcontent on how to operate particular features of the system, whichfacilitates new user training.

Referring now to FIG. 24, the pump system 600 comprises a reusable pumpdevice that houses both the controller circuitry and the pump drivesystem. Similar to previously described embodiments, the pump system 600can include a housing structure that defines a cavity in which amedicine cartridge can be received. For example, the pump system 600 canbe adapted to receive a medicine cartridge in the form of a carpule thatis preloaded with insulin or another medicine. The pump drive system canact upon the fluid cartridge to controllably dispense medicine throughan infusion set 146 and into the user's tissue or vasculature. The usercan wear the portable pump system 600 on the user's skin under clothingor in the user's pocket while receiving the medicine dispensed throughthe infusion set 146.

The infusion pump system 600 in this embodiment also includes a mediacontent playback system 630 that can playback media content to the userwhile the pump system 600 is delivering the medicine to the user.Similar to previously described embodiments, the playback system 630 maycomprise an external audio device 631 that plugs into a connection portalong the pump housing so as to mate with an audio output device (e.g.,an audio jack or the like). The external audio device 531 may includeearbuds 635 or another listening device that deliver sound to the user'sear while the pump system 600 is carried by the user. At least onememory device arranged in the pump system 600 can be used toelectronically store a number of media content files available forplayback to the user. Accordingly, the user can operate a user interface620 of the infusion pump system 600 so as to receive controlled deliveryof a medicine while also listening to the playback of selected MP3 musicor other media content.

Still referring to FIG. 24, the user interface 620 includes a displaydevice 622 and one or more user-selectable buttons 624 a and 624 b. Thedisplay device 622 can include an active area in which numerals, text,symbols, images, or a combination thereof can be displayed. For example,the display device 622 can be used to communicate media contentinformation 626, which may related to the selected media content that isbeing delivered to the user through the playback system 630. Also, thedisplay device 622 can be used to communicate medicinal deliveryinformation 627, such as the basal delivery rate (as shown in FIG. 24)or the like. Similar to previously described embodiments, the user maypress one or more of the buttons 624 a and 624 b to shuffle through anumber of menus or program screens that show particular settings anddata related to the medicine dispensation. Also, the user can adjust thesettings or otherwise program the pump system 600 by pressing one ormore buttons 624 a and 624 b of the user interface 620. In anotherexample, the user can press one or more of the buttons 624 a and 624 bso as to play, pause, rewind, or fast-forward the selected media content626 or to otherwise control the output of media content through theplayback system 630. Accordingly, the user can contemporaneously monitorthe operation of the pump system 600 and control the media contentplayback from the same user interface 620. Similar to previouslydescribed embodiments, the pump system 600 can be configured tointerrupt the music content or other media content in order to deliveran alarm via the user's external audio device 631, thereby enhancing theuser safety. Also, the media content played by the pump system 600 mayinclude an audio tutorial or other instructional content on how tooperate particular features of the system, which facilitates new usertraining.

Referring now to FIG. 25, the infusion pump system 10 depicted in FIGS.1-3 can be configured to interrupt the playback of media content when analarm condition has been detected. As such, the pump system 10 canexecute a process 700 that communicates the alarm condition to the user.It should be understood from the description herein that the system 400,500, and 600 can also be configured to operate as described in FIG. 25so as to interrupt the playback of media content when an alarm conditionhas been detected.

The process 700 includes the operation 710 of operating the infusionpump according to the set parameters. For example, during normal usage,the pump device can dispense the medicine to the user in a controlledmanner according to a selected basal rate. In operation 720, an alarmcondition is detected by the infusion pump system. As previouslydescribed, the alarm condition may comprise an occlusion in the infusionset tubing 147, low battery power, low medicine remaining in thecartridge, a missed bolus dosage, or the like.

As shown in FIG. 25, the infusion pump system 10 can perform operation730 so as to determine whether media content is being delivered to theuser via an audio device. For example, the control circuitry can beequipped to detect whether the external audio device 231 is plugged intothe audio jack 232 (refer to FIG. 17). In addition or in thealternative, the control circuitry can be used to determine whether themedia content playback software has been activate to deliver mediacontent to the user. If the operation 730 reveals that the media contentis being delivered to the user, the process 700 proceeds to operation740 in which the playback is interrupted to provide an audible alert viathe audio device (e.g., a beep or voice warning is communicated via theearbuds 235 or the like). Alternatively, if the operation 730 revealsthat no media content is being delivered, the pump system 10 proceeds tooperation 760 in which an alert (e.g., an audible beep, a vibrationalarm, a display alarm, or the like) external to the audio device isprovided to the user.

Referring again to operation 740, after the playback of the mediacontent has been interrupted to provide the alert, the process 700proceeds to operation 750 in order to determine if the alarm has beenacknowledged, cleared, or otherwise resolved by the user. For example,as previously described in connection with FIG. 3, the user can actuatea button on the user interface 220 to acknowledge that the alarm wasreceived. If the alarm is acknowledge or otherwise resolved, the process700 cycles back to operation 710 where the pump system 10 functionsaccording to the set parameters. If the alarm is not acknowledge orotherwise resolved, the process 700 can proceed to previously describedoperation 760 in which an alert (e.g., an audible beep, a vibrationalarm, a display alarm, or the like) external to the audio device isprovided to the user.

If the process reaches operation 760 to provide the alert external tothe audio device, the process then determines in operation 770 if thealarm was acknowledged, cleared, or otherwise resolved by the user. Ifyes, the process 700 cycles back to operation 710 where the pump system10 functions according to the set parameters. However, if the alarm hasnot been acknowledged or otherwise resolved, the process 700 proceeds tooperation 780 in which the pump system 10 begins to operate in anemergency mode. The emergency mode can include a number of differentoperations depending upon the alarm condition that was detected. Forexample, the emergency mode may comprise a series of incrementallylouder alarms that are intended to be heard from a distance away fromthe pump system (e.g., to get attention from others near the user). Inanother example, the emergency mode may comprise a shutdown ofnon-medical features so as to preserve the remaining battery power formedicine dispensation purposes. If the alarm condition is subsequentlyresolved, the user may operate the user interface 220 so as to returnthe pump system 10 to normal operation according to the set parameters.

Referring now to FIG. 26, the infusion pump system 10 depicted in FIGS.1-3 can be configured to provide instruction media content to the userin response to a detected event. As such, the pump system 10 can executea process 800 that permits a new user to readily receive a tutorial orother instructions related to the pump system 10. It should beunderstood from the description herein that the system 400, 500, and 600can also be configured to operate as described in FIG. 26 so as toprovide instruction media content to the user.

The process 800 includes the operation 810 of detecting an event, suchas the startup of a new pump device in this particular embodiment.Thereafter, the process 800 proceeds to operation 820 in which the useris prompted to indicate if instructional media content should bedelivered to the user. The instruction media content can be related tothe detected event. For example, in this embodiment the event is thestartup of a new pump device. As such, the instructional media contentmay comprise an audio tutorial that relates to the preparation of thenew pump device in order to begin dispensing medicine to the user. Inoperation 830, the pump system 10 receives user input that indicates ifthe instructional media content should be played (e.g., playback throughthe external audio device 231). If the user indicates “no,” theinstructional content is not provided and the process 800 proceeds tooperation 860 in which the pump system delivers medicine according toset parameters. Alternatively, if the user indicates “yes,” the process800 continues to operation 840 so that the instructional content isoutput via an audio device (e.g., external audio device 231 havingearbuds or the like). In such circumstances, the playback system 230 canprovide verbal instructions to the user.

After the instructional content is provided, the process 800 may proceedto operation 850 to query the user on whether the instruction contentwas properly received. If “no,” the process 800 cycles back to operation830 to determine if the instructional media content should be played tothe user. If the user indicates “yes” for operation 850, the process 800proceeds to operation 860 in which the pump system delivers medicineaccording to set parameters.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

1. (canceled)
 2. A medical infusion pump system, comprising: a portable,wearable housing defining an interior space to receive insulin; a pumpdrive system positioned in the portable housing and configured todispense insulin to a user from the portable, wearable housing when theinsulin is received in the space; and a controller in communication withthe pump drive system positioned in the portable, wearable pump housingso as to transmit activation signals for the pump drive system, thecontroller including a user interface comprising at least a displaydevice and an audio output device, the user interface allowing a user torequest that a bolus of insulin be dispensed from the portable, wearablehousing; the controller further including a memory device that storesdigital music content for playback through the audio output device, thecontroller is configured to output an audible alert through the audiooutput device, the audible alert being indicative of a detected alarmcondition of the infusion pump system, wherein outputting the audiblealert includes stopping playback of the digital music content.
 3. Thesystem of claim 2, wherein the controller is further configured tooutput a visual alert through the display device, the visual alert beingindicative of the detected alarm condition.
 4. The system of claim 2,wherein the controller is further configured to restart playback of thedigital music content through the audio output device in response to thecontroller receiving user input on the user interface indicating thatthe detected alarm condition is acknowledged or resolved.
 5. The systemof claim 2, wherein the playing of the digital music content istemporarily stopped and automatically resumed after the outputting ofthe audible alert.
 6. The system of claim 2, wherein the controller isfurther configured to output a different audible alert through the audiooutput device in response to detection of a different detected alarmcondition, the different detected alarm condition being of a differenttype than the detected alarm condition.
 7. The system of claim 6,wherein the controller is configured to restart playback of the digitalmusic content through the audio output device in response to thecontroller receiving user input on the user interface indicating thatthe detected alarm condition is acknowledged or resolved and totemporarily stop playback of the digital music content and automaticallyresuming playback of the digital music content after outputting thedifferent audible alert.
 8. The system of claim 7, wherein the detectedalarm condition requires immediate intervention and the differentdetected alarm condition does not require immediate intervention.
 9. Thesystem of claim 2, wherein the controller is further configured todetermine that the detected alarm condition is resolved and restartplayback of the digital music content through the audio output device inresponse in to determining that the detected alarm condition isresolved.
 10. The system of claim 2, wherein the controller is furtherconfigured to determine that the detected alarm condition is notresolved and continue outputting the audible alert through the audiooutput device in response to determining that the detected alarmcondition is not resolved.
 11. The system of claim 10, wherein thecontroller is further configured to enter an emergency mode of operationin response to determining that the detected alarm condition is notresolved.
 12. The system of claim 11, wherein entering the emergencymode of operation includes outputting a series of incrementally louderalarms.
 13. The system of claim 2, wherein the user interface of thecontroller contemporaneously displays insulin delivery information andmedia content playback information on a display screen of the userinterface.
 14. The system of claim 2, wherein the audible alert includesinstructions on how to respond to the detected alarm condition.
 15. Amethod of using a medical infusion pump system, comprising: outputtingdigital music content through an audio output device of a medicalinfusion pump system, the medical infusion pump system comprising: aportable, wearable housing defining an interior space to receiveinsulin; a pump drive system positioned in the portable housing andconfigured to dispense insulin to a user from the portable, wearablehousing when the insulin is received in the space; and a controller incommunication with the pump drive system positioned in the portable,wearable pump housing so as to transmit activation signals for the pumpdrive system, the controller including a user interface comprising atleast a display device and the audio output device, the controllerfurther including a memory device that stores the digital music contentfor playback through the audio output device; detecting, by thecontroller, an alarm condition of the medical infusion pump system;stopping, in response to detecting the alarm condition, playback of thedigital music content through the audio output device; outputting, inresponse to detecting the alarm condition and after stopping playback ofthe digital music content, an audible alert through the audio outputdevice, the audible alert being indicative of the detected alarmcondition; and displaying, on the display device, a message indicatingthat playback of the digital music content has been stopped due to thedetected alarm condition.
 16. The method of claim 15, further comprisingdisplaying, on the display device, a visual alert indicative of thedetected alarm condition, the visual alert including instructions on howto respond to the detected alarm condition.
 17. The method of claim 15,further comprising: determining, by the controller, that the detectedalarm condition is not resolved; and continuing to output the audiblealert through the audio output device in response to determining thatthe detected alarm condition is not resolved.
 18. The method of claim17, further comprising entering, by the controller, an emergency mode ofoperation in response to determining that the detected alarm conditionis not resolved.
 19. The method of claim 15, further comprising:determining, by the controller, that the detected alarm condition isresolved; and restarting playback of the digital music content throughthe audio output device in response determining that the detected alarmcondition is resolved.
 20. The method of claim 15, further comprisingreceiving user input on the user interface indicating that the detectedalarm condition is acknowledged or resolved.
 21. The method of claim 20,further comprising restarting playback of the digital music contentthrough the audio output device in response to receiving the user input.